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Medical Devices Healthcare The United States Federal Communications Commission

Mintz - Health Care Viewpoints

Regulatory Challenges for the New Frontier of Medical Imaging: Terahertz Spectrum

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC). While the Food and Drug...more

Buchalter

Health Care and Life Sciences Practice Newsletter

Buchalter on

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Baker Donelson

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

Baker Donelson on

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Foley & Lardner LLP

Recommendations for NextGen Health IT Infrastructure

Foley & Lardner LLP on

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

Foley & Lardner LLP

Finally…FDASIA Health IT Regulation Report Released

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

Fenwick & West Life Sciences Group

The Regulatory Future of mHealth: FCC, FDA and the United States Congress

As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more

Mintz - Health Care Viewpoints

mHealth Alert: Text4baby: Texting Health Messages to Pregnant Women and New Moms

Furthering the use of commercial wireless networks to deliver health information, the Obama Administration recently announced its new Text4baby campaign, which sends free regular text messages with health information to...more

Mintz - Health Care Viewpoints

mHealth Alert: FCC Extends Boston Scientific's Authority for Implanted Cardiac Devices

The Federal Communications Commission (FCC) recently granted a rule waiver requested by Boston Scientific Corporation (Boston Scientific), allowing it to continue to manufacture and market its Contak Renewal TR product line...more

Mintz - Health Care Viewpoints

mHealth Alert: mHealth Raise New FCC and FDA Issues

Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new “mHealth” (mobile...more

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